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NCT Number: NCT05049057

Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

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Key information

Conditions

Posttraumatic Headache Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Disorders Headache Disorders, Secondary Mild Traumatic Brain Injury Nervous System Diseases Post-Traumatic Headache Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Womack Army Medical Center - Fort Liberty, Fort Bragg, North Carolina, United States

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About this study

Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 and ≤50 years of age
  • mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
  • PTH has occurred within the prior 7 days
  • Able to provide informed consent
  • Likely to stay in the same geographical area for the duration of study
  • Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider

Exclusion criteria

  • Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
  • abnormal structural imaging
  • loss of consciousness for >30 minutes
  • alteration of consciousness/mental state for >24 hours 3. post-traumatic amnesia for >1 day
  • Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Treatment and study plan

Erenumab 140 Mg/mL Subcutaneous Solution

Drug

Active erenumab delivered via subcutaneous injection.

Other names: Aimovig

Placebo

Drug

Placebo delivered via subcutaneous injection.

Primary outcomes

  1. Monthly Headache Days

    Time frame: Week 8 to Week 12

    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

Secondary outcomes

  1. Monthly Headache Days

    Time frame: Week 0 to Week 12

    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  2. Monthly Headache Days

    Time frame: Week 0 to Week 4

    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  3. Monthly Headache Days

    Time frame: Week 0 to Week 8

    Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary

  4. Adverse Events

    Time frame: Week 0 to Week 12

    Number of adverse events reported in erenumab group compared to placebo

  5. Return to Full Duty

    Time frame: Week 0 to Week 12

    Time to return to full activity as measured by the daily headache diary

  6. Concomitant Medications

    Time frame: Week 0 to Week 12

    Monthly use of medications for acute headache treatment

  7. Headache Days

    Time frame: Week 0 to Week 12

    Monthly headache days after early acute versus late acute administration of erenumab compared to placebo

  8. HPFID Activity

    Time frame: Week 0 to Week 12

    Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1

  9. HPFID Physical Impairment

    Time frame: Week 0 to Week 12

    Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2

  10. HIT-6

    Time frame: Week 0 to Week 12

    Change from baseline in headache impact scores as measured by the Headache Impact Test

  11. PHQ-9

    Time frame: Week 0 to Week 12

    Change from baseline in depressive symptoms after mTBI as measured by the self-report questionnaire, Patient Health Questionnaire-9, Total Score. Total scores range from a minimum of 0 to a maximum of 27, which are rated from minimal to severe levels of depression.

  12. ISI

    Time frame: Week 0 to Week 12

    Change from baseline in insomnia scores as measured by the Insomnia Severity Index

Other outcomes

  1. MSQ

    Time frame: Week 0 to Week 12

    Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire

  2. ASC-12

    Time frame: Week 0 to Week 12

    Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist

  3. ANAM

    Time frame: Week 0 to Week 12

    Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics

  4. Function of Time

    Time frame: 0-24 hours, 24-72 hours, 72-144 hours

    Effect of erenumab compared to placebo as a function of time from mTBI to first dose of erenumab as measured by the daily headache diary

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Guthrie, RN

CONTACT

[email protected]

202-924-2729

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Registry information

Official study title

Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 17, 2021
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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